11 completed. 11 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 11 |
| Phase 2 | 1 | Completed 1 |
Follow Tolvaptan: new trials by email Literature Review of Tolvaptan trials Research Report on Tolvaptan
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of HRS-9057 in Patients With Heart Failure and Volume Overload HRS-9057, Tolvaptan - Heart Failure With Volume Overload | Phase 1 | Completed | Fujian Shengdi Pharmaceutical Co., Ltd. | 25 | 2024-08-16 | 2025-11-17 |
| A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects OPC-41061 - Healthy Adult Male | Phase 1 | Completed | Otsuka Pharmaceutical Co., Ltd. | 84 | 2017-01-06 | 2021-06-28 |
| AiDing Diuresis wIth Tolvaptan (ADD-IT) Tolvaptan 30 mg + IV Diuretics, Metolazone 5 mg + IV Diuretics, 2.5 times the Diuretics Dose - Cardiomyopathy, Congestive Heart Failure | Phase 1 | Completed | Emory University | 14 | 2016-01-01 | 2019-03-27 |
| Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study Tolvaptan, Placebo - Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Calcium Phosphate | Phase 1 | Completed | Mayo Clinic | 20 | 2014-03-01 | 2016-03-30 |
| A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) tolvaptan - Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) | Phase 1 / Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 30 | 2013-11-01 | 2016-05-16 |
| The Role of Vasopressin Antagonism on Renal Sodium Handling Tolvaptan Oral Tablet - Healthy | Phase 1 | Completed | Brigham and Women's Hospital | 30 | 2012-02-01 | 2019-04-10 |
| Single Dose of 7.5mg Tolvaptan Phase I Clinical Trial Protocol Tolvaptan - Health Subjects | Phase 1 | Completed | Otsuka Beijing Research Institute | 10 | 2011-06-16 | 2025-09-10 |
| Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Male Tolvaptan - Healthy Subjects | Phase 1 | Completed | Otsuka Beijing Research Institute | 12 | 2011-06-07 | 2025-09-10 |
| Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact Tolvaptan - Healthy | Phase 1 | Completed | University of North Carolina, Chapel Hill | 29 | 2011-01-01 | 2012-12-07 |
| Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy Male Tolvaptan 15mg or 30mg or 60mg or Placebo - Healthy | Phase 1 | Completed | Korea Otsuka Pharmaceutical Co., Ltd. | 46 | 2010-01-01 | 2010-03-11 |
| Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis tolvaptan - Hepatic Cirrhosis, Ascites | Phase 1 | Completed | Otsuka Beijing Research Institute | 11 | 2009-04-01 | 2011-05-24 |
Ascites (1) · Cardiomyopathies (1) · Heart Failure (1) · Inappropriate ADH Syndrome (1) · Kidney Calculi (1) · Liver Cirrhosis (1) · Nephrolithiasis (1) · Nephrolithiasis, Calcium Oxalate (1)
Otsuka Beijing Research Institute (3) · Brigham and Women's Hospital (1) · Emory University (1) · Fujian Shengdi Pharmaceutical Co., Ltd. (1) · Korea Otsuka Pharmaceutical Co., Ltd. (1) · Mayo Clinic (1) · Otsuka Pharmaceutical Co., Ltd. (1) · Otsuka Pharmaceutical Development & Commercialization, Inc. (1) · University of North Carolina, Chapel Hill (1)
United States (3) · China (2) · Czechia (1) · Denmark (1) · Germany (1) · Hungary (1) · Japan (1) · South Korea (1) · Spain (1) · Sweden (1) · United Kingdom (1)
Divya Gupta, MD (1) · Elizabeth B McNeely, PharmD (1) · J. Herbert Patterson, PharmD (1) · John Lieske, MD (1) · Jonathan S Williams, MD, MMSc (1) · Kyung-Sang Yu, MD (1) · Minde Zeng (1)